Associate Manager, Regulatory Labeling Operations

Location
Tarrytown, New York, United States of America
Posted
Jun 12, 2021
Ref
24409BR
Required Education
Bachelors Degree
Position Type
Full time
The Regulatory Affairs Labeling Operations Manager is responsible for the regulatory role as part of the process for coordination, development and implementation of new and revised printed labeling for assigned commercial products as well as products in full development.

In this role, a typical day might include the following:
  • Leads the development, revision, preparation and internal approval of packaging artworks e.g., carton, container label, printed package insert, for assigned development products as well as marketed products. Strong understanding of industry labeling trends related to packaging and labeling content and implementation, reviewing competitor and other labeling. Interpret labeling regulations and guidance, determining company impact and providing direction as appropriate.
  • Provide functional expertise at relevant department meetings and relevant cross functional subteams.
  • Lead packaging team to ensure packaging content and artworks are aligned with internal labeling policies, standard operating procedures and worldwide health authority regulations.
  • Contribute and handle Annual Reports for assigned products.
  • Maintain and track packaging artwork lifecycle and documents in appropriate labeling repository and electronic systems.
  • Lead and review preparation of SPL.
  • Perform/manage proofreading as requested by Labeling Lead.
  • Monitor the worldwide regulation changes pertaining to Labeling regulations and author the maintenance of the labeling SOP and work instructions.
  • Assist labeling staff and other subteam members in labeling operations project and process management to build expertise and awareness.
  • Independently determines methods and procedures on new assignments and coordinates activities/providing technical guidance to others.
  • Work independently across multiple areas.
This role might be for you if:
  • Bachelor's degree (BS) from an accredited college or university, preferably in the field of Health/Science OR 6+ years of validated experience.
  • Demonstrates strong knowledge of worldwide Regulatory Agencies, industry practice, packaging manufacturing process, and drug development process, including. FDA, EMEA, and international packaging regulations and industry practices for biologic and combination product.
  • Good working knowledge of Microsoft Office applications.
  • proven experience with 4 or more within in the regulatory labeling and packaging area.
  • Experience contributing to the development of department strategy, operational objectives, and matters of significance.
  • Ability to apply knowledge and skills to aid resolving highly complex issues where the analysis of situations or data requires an in-depth evaluation of intangibles or situations with minimal precedent.
  • Provide strong concepts to develop innovative business solutions.
  • Strong knowledge and experience of the labeling/packaging process and related issues in medical safety regulatory and/or corporate.
  • Ability to lead Packaging Team to address packaging issues, develop plans of action, and oversee completion of packaging project.
  • Ability to proactively share information with peers and generate discussion to resolve complex issues.
  • Lead multiple projects and prioritize work with limited supervision.
  • Attention to detail and strong organizational skill.


Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.